Excisional biopsy devices and methods

• US 6,764,495 B2
• Filed: 03/14/2002
• Issued: 07/20/2004
• Est. Priority Date: 09/03/1998
• Status: Expired due to Fees

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Vetter, James W., Lee, Roberta
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/098,014
• Publication Number:
  US 20020095100A1
• Time in Patent Office: 859 Days
• Field of Search: 606/159, 606/170, 606/167, 606/180, 600/564-567
• US Class Current: 606/159
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/461 Displaying means of special interest

Abstract

An excisional biopsy device includes a tubular member having a window near a distal tip thereof; a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of the window and to retract within the window; and a tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue excised by the cutting tool as the biopsy device is rotated and the cutting tool is bowed. An excisional biopsy method for soft tissue includes the steps of inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue. The tubular member may include an imaging transducer and the method may include the step of displaying information received from the transducer on a display device and the step of varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer. Alternatively, the imaging transducer may be disposed within a removable transducer core adapted to fit within the tubular member.

Claims

1. An excisional biopsy method for soft tissue, comprising the steps of:

inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member;

rotating the tubular member;

selectively varying a degree of bowing of the cutting tool;

collecting tissue severed by the cutting tool in the tissue collection device; and

retracting the tubular member from the soft tissue.

2. The method of claim 1, wherein the rotating step is carried out by manually rotating the tubular member.

3. The method of claim 1, wherein the tubular member further includes an imaging transducer and wherein the method further comprises the steps of:

displaying information received from the transducer on a display device; and

varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer.

4. The method of claim 3, wherein the cutting tool comprises an electrosurgical blade and wherein the method further comprises the step of varying a power applied to the electrosurgical blade based upon information received from the transducer.

5. The method of claim 1, further comprising the step of stabilizing the soft tissue in an uncompressed state prior to the inserting step.

6. The method of claim 1, further comprising the step of controlling the cutting tool to assume a non-extended state prior to the inserting step and before the retraction step.

7. The method of claim 6, wherein the tissue collection device assumes a closed configuration when the cutting tool assumes the non-extended state.

8. The method of claim 1, wherein the extension of the cutting tool is controlled by selectively and manually pushing and retracting a proximal end of the cutting tool in the distal and proximal directions, respectively.

9. The method of claim 1, wherein the cutting tool comprises an interior lumen and a plurality of through holes in fluid communication therewith, and wherein the method further comprises the step of delivering at least one fluid to the tissue via the plurality of through holes.

10. An imaging and treatment method for soft tissue, comprising the steps of:

inserting a tubular member into the soft tissue, the tubular member including an ultrasonic transducer mounted within and near a distal end of the tubular member;

rotating the tubular member within the soft tissue;

displaying an output of the ultrasonic transducer on a display device; and

acting upon the soft tissue based upon the displayed output.

11. The method of claim 10, wherein the ultrasonic transducer is tuned to within a frequency range of between about 7.5 MHz to about 20 MHz.

12. The method of claim 10, wherein the acting step includes a step of excising a selectively variable volume of soft tissue from a main tissue mass.

13. The method of claim 12, further including a step of collecting the excised volume of tissue in a tissue collection device mounted externally to the tubular member.

14. Method of excising a lesion from soft biological tissue using an excisional biopsy system including a generally tubular member having a cutting tool, a removable transducer core adapted to fit within the tubular member and an expandable sheath, comprising the steps of:

fitting the transducer care through the expandable sheath,

inserting the transducer and sheath though an incision in the tissue;

imaging a target site within the tissue by energizing the transducer core,

removing the transducer core from sheath while leaving the sheath in place within the tissue;

securing the core within the generally tubular member so the core faces outwardly from the tubular member;

sliding the tubular member through the expandable sheath until the cutting tool is positioned adjacent the lesion;

cutting the lesion with the cutting tool; and

retracting at least the tubular member from the incision.

15. The method of claim 14, further comprising the step of stabilizing the breast in one of an uncompressed and a slightly expanded state prior to the inserting step.

16. The method of claim 14, wherein the sheath remains within the tissue after the retracting step and wherein the method further comprises the step of:

re-inserting the transducer core within the sheath and imaging the target site to insure that the lesion has been excised.

17. The method of claim 14, further comprising the step of collecting the cut lesion within an external tissue collection device secured to the tubular member.

18. The method of claim 14, wherein both the tubular member and the sheath are retracted from the incision.